FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K971446 |
07/18/1997 |
3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160) |
3M COMPANY |
LINDA JOHNSEN |
K971697 |
07/14/1997 |
ETEST FOR LEVOFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
K965230 |
07/03/1997 |
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP |
ABBOTT MFG., INC. |
DAVID GUZEK |
K972195 |
07/29/1997 |
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) |
ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD. |
WOLFE BIRKIE |
K972177 |
07/29/1997 |
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) |
ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD. |
WOLFE BIRKIE |
K972100 |
07/31/1997 |
VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) |
ADVANCED CARE MEDICAL PRODUCTS |
STEVEN FAINSZTEIN |
K970644 |
07/31/1997 |
AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM |
AEROQUIP MEDICAL PRODUCTS |
CHRISTINA L THOMAS |
K971310 |
07/18/1997 |
AESCULAP JET IRRIGATION SYSTEM |
AESCULAP, INC. |
MARY ELLEN HOLDEN |
K970384 |
07/29/1997 |
VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 |
AKTINA MEDICAL PHYSICS CORP. |
JOAN ZACHAROPOULOS |
K971618 |
07/14/1997 |
ALCON CONTACT LENS CASE |
ALCON LABORATORIES |
MICHEAL E PFLEGER |
K971604 |
07/28/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
K971826 |
07/03/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
K971865 |
07/03/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
K972084 |
07/03/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
K972089 |
07/03/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
K971866 |
07/03/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
K962767 |
07/03/1997 |
MS401097-17,MS722-K,MS720,MS721,MS722 |
ALEXANDER MFG. CO. |
JON GAMERDINGER |
K972291 |
07/28/1997 |
ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
MARYALICE SMITH |
K971381 |
07/09/1997 |
POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
MARYALICE SMITH |
K971988 |
07/11/1997 |
ALLEN, ULTRA AND SMART SOCKETS |
ALLEN MEDICAL SYSTEMS, INC. |
SUZANNE KAY RATZLOFF |
K971478 |
07/18/1997 |
DURALASTIC ANATOMICAL CHIN IMPLANTS |
ALLIED BIOMEDICAL CORP. |
GERALD HANSON |
K971479 |
07/18/1997 |
DURALASTIC ANATOMICAL MALAR IMPLANTS |
ALLIED BIOMEDICAL CORP. |
GERALD HANSON |
K971481 |
07/18/1997 |
DURALASTIC ANATOMICAL NASAL IMPLANTS |
ALLIED BIOMEDICAL CORP. |
GERALD HANSON |
K972452 |
07/24/1997 |
RAMY INTEGRATED NEEDLE SYRINGE |
ALSHIFA MEDICAL SYRINGES MFG. CO., LTD. |
MILTON N BENEKE, JR. |
K971664 |
07/25/1997 |
RAMY PISTON SYRINGE |
ALSHIFA MEDICAL SYRINGES MFG. CO., LTD. |
MILTON N BENEKE |
K972190 |
07/14/1997 |
THYROGLOBULIN ASSAY SYSTEM |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD CONLEY |
K971512 |
07/24/1997 |
AMS COAGULOOP RESECTION ELECTRODE |
AMERICAN MEDICAL SYSTEMS, INC. |
JOHN M OTTO |
K971332 |
07/09/1997 |
AMS MAINSTAY UROLOGIC BONE ANCHOR |
AMERICAN MEDICAL SYSTEMS, INC. |
JOHN M OTTO |
K962539 |
07/14/1997 |
GANTEX MODEL NSG-75PF |
AMERICAN PRO LATEX, INC. |
ROSS LITTON |
K963574 |
07/18/1997 |
PULSE*SPRAY INJECTOR |
ANGIODYNAMICS, INC. |
JEFFREY R MANNION |
K971758 |
07/21/1997 |
CAUTERIZATION SMOKE EVACUATOR |
APPLIED MEDICAL TECHNOLOGIES |
THOMAS W PARKINSON |
K971457 |
07/16/1997 |
BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED |
ARCAN ORTHOPAEDIC CORP. |
DONALD W BRYAN |
K971699 |
07/03/1997 |
ARGOSY DYNAMEQ |
ARGOSY ELECTRONICS |
DENNIS J DAVIS |
K955668 |
07/30/1997 |
INTRACAVITY NEEDLE GUIDE KIT |
ARLANDA MEDICINSKA INSTRUMENT CO. AB |
GINA AZARIC |
K970080 |
07/25/1997 |
ARROW-TREROTOLA PTD CATHETER |
ARROW INTL., INC. |
THOMAS D NICKEL |
K971358 |
07/09/1997 |
BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM |
ARTHREX, INC. |
JONATHAN S KAHAN |
K971723 |
07/30/1997 |
FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) |
ARTHREX, INC. |
SCOTT M DURLACHER |
K971532 |
07/23/1997 |
ARTHROCARE ELECTROSURGERY SYSTEM |
ARTHROCARE CORP. |
CHERYL SHEA |
K963790 |
07/21/1997 |
UNI-GRAFT K DV |
ATRIUM MEDICAL CORP. |
TED KARWOSKI |
K971105 |
07/11/1997 |
MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM |
AVECOR CARDIOVASCULAR, INC. |
DENNIS E STEGER |
K971318 |
07/28/1997 |
MM-1 MOVEMENT MONITOR |
AXON INSTRUMENTS, INC. |
ANDREW L BLATZ |
K972672 |
07/29/1997 |
BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY |
BARZELL-WHITMORE MAROON BELLS, INC. |
MARIAN HARDING COCHRAN |
K972159 |
07/23/1997 |
FENWAL 40 MICRON TRANSFUSION FILTER |
BAXTER HEALTHCARE CORP. |
MARY E SNYDER |
K971168 |
07/15/1997 |
ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE |
BAXTER HEALTHCARE CORP. |
PATRICIA S BARSANTI |
K972404 |
07/22/1997 |
VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
JOHN SCHALAGO |
K972098 |
07/28/1997 |
FOSFOMYCIN, 200 MG, SENSI-DISC |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
VIRGINIA C WEINKNECHT |
K972011 |
07/22/1997 |
OPUS ETHANOL |
BEHRING DIAGNOSTICS, INC. |
Ruth Forstadt |
K972116 |
07/25/1997 |
VON WILLEBRAND REAGENT |
BEHRING DIAGNOSTICS, INC. |
PAUL L ROGERS |
K963512 |
07/31/1997 |
BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL |
BENZ RESEARCH AND DEVELOPMENT CORP. |
MARTIN DALSING |
K963744 |
07/31/1997 |
BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK) |
BENZ RESEARCH AND DEVELOPMENT CORP. |
MARTIN DALSING |
K965130 |
07/14/1997 |
CHROMOPHARE |
BERCHTOLD HOLDING GMBH |
W. HILL |
K971744 |
07/28/1997 |
FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) |
BERKLEY MEDICAL RESOURCES, INC. |
FRANK R DASTOLI |
K971298 |
07/23/1997 |
BETTER HEARING, INC. MODEL L-1 HEARING AID |
BETTER HEARING, INC. |
LOUIS T GNECCO |
K972131 |
07/18/1997 |
BREATH ACE BREATHFRESHENER |
BEYOND 21ST CENTURY, INC. |
HEMANT K THAKUR |
K972024 |
07/30/1997 |
CODA AUTOMATED EIA ANALYZER |
BIO-RAD |
JOHN W NELSON |
K971761 |
07/22/1997 |
PERSONALLAB AUTOMATED MICROPLATE ANALYZER |
BIOCHEM IMMUNOSYSTEMS (U.S.), INC. |
JAMES SAFRANKO |
K971782 |
07/29/1997 |
BONE AND MARROW COLLECTION SYSTEM KIT |
BIOMEDICAL ENT., INC. |
W. CASEY FOX |
K971268 |
07/03/1997 |
BONE & MARROW CLLECTION SYSTEM |
BIOMEDICAL INTERNATIONAL CORP. |
CASEY FOX |
K971816 |
07/18/1997 |
ATLAS FRACTURE PROXIMAL HUMERAL NAIL |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
K971942 |
07/23/1997 |
SLED, FINGER, HANDLE |
BIOSOUND ESAOTE, INC. |
GERALD A RICHARDSON |
K971700 |
07/09/1997 |
BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER |
BIOSOUND, INC. |
GERALD A RICHARDSON |
K962060 |
07/23/1997 |
STREP A OIA MAX |
BIOSTAR, INC. |
LYNDAL K HESTERBERG |
K964190 |
07/10/1997 |
ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER |
BIOTRONIK, INC. |
Joseph J Schwoebel |
K970484 |
07/01/1997 |
ACCU-PREP |
BISCO, INC. |
JAMES L SANDRIK |
K964439 |
07/16/1997 |
NEEDLE-FREE VALVED CONNECTOR AND CAP |
BMW MEDICAL, INC. |
ROGER L RICHINS |
K972433 |
07/24/1997 |
CEDIA DIGOXIN CALIBRATORS |
BOEHRINGER MANNHEIM CORP. |
Yvette Lloyd |
K964351 |
07/25/1997 |
ELECSYS PSA ASSAY |
BOEHRINGER MANNHEIM CORP. |
MARY KONING |
K971060 |
07/07/1997 |
PRECINORM TDM CONTROLS |
BOEHRINGER MANNHEIM CORP. |
Yvette Lloyd |
K964282 |
07/30/1997 |
TINA-QUANT FERRITIN ASSAY |
BOEHRINGER MANNHEIM CORP. |
Yvette Lloyd |
K972513 |
07/28/1997 |
TINAQUANT MYOGLOBIN ASSAY |
BOEHRINGER MANNHEIM CORP. |
Yvette Lloyd |
K972096 |
07/15/1997 |
BIVALVE NASAL SPLINT |
BOSTON MEDICAL PRODUCTS, INC. |
STUART K MONTGOMERY |
K972082 |
07/03/1997 |
CUSTOM NASAL SPLINT |
BOSTON MEDICAL PRODUCTS, INC. |
STUART K MONTGOMERY |
K972151 |
07/07/1997 |
DOYLE COMBO NASAL AIRWAY SPLINT |
BOSTON MEDICAL PRODUCTS, INC. |
STUART K MONTGOMERY |
K972092 |
07/08/1997 |
NASAL AIRWAY SPLINT |
BOSTON MEDICAL PRODUCTS, INC. |
STUART K MONTGOMERY |
K972060 |
07/03/1997 |
NASAL SEPTAL BUTTON |
BOSTON MEDICAL PRODUCTS, INC. |
STUART K MONTGOMERY |
K972078 |
07/10/1997 |
POST-STOP EPISTAXIS CATHETER |
BOSTON MEDICAL PRODUCTS, INC. |
STUART K MONTGOMERY |
K971165 |
07/23/1997 |
INTRODUCER SHEATH AND DILATOR |
BOSTON SCIENTIFIC CORP. |
WANDA M CARPINELLA |
K971607 |
07/24/1997 |
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS |
BOSTON SCIENTIFIC CORP. |
ANGELA RAUN |
K970207 |
07/31/1997 |
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS |
BOSTON SCIENTIFIC CORP. |
ANGELA RAUN |
K971254 |
07/01/1997 |
TRANSEND EX PLATINUM GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
MARY P LEGRAW |
K965123 |
07/17/1997 |
PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE) |
BURKE, INC. |
DUWAYNE E KRAMER |
K971180 |
07/24/1997 |
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT |
C.R. BARD, INC. |
SANDRA L PERREAND |
K970375 |
07/25/1997 |
ANNULOFLO SYSTEM |
CARBOMEDICS, INC. |
MICHAEL C MORTON |
K964836 |
07/28/1997 |
CARD GUARD, MODEL CG-7100 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
LEONID TRACHTENBERG |
K970461 |
07/11/1997 |
CELL ROBOTICS ER: YAG SURGICAL LASER |
CELL ROBOTICS, INC. |
CONNIE WHITE |
K960587 |
07/21/1997 |
CPROTECTOR 2000 |
CERTIFIED SAFETY MFG., INC. |
HOWARD GERSON |
K971019 |
07/21/1997 |
CHASE VESSEL CANNULA |
CHASE MEDICAL, INC. |
BERT DAVIS |
K970546 |
07/14/1997 |
ACS DIGITOXIN |
CHIRON DIAGNOSTICS CORP. |
THOMAS F FLYNN |
K971418 |
07/17/1997 |
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER |
CHIRON DIAGNOSTICS CORP. |
William J Pignato |
K972012 |
07/24/1997 |
CHOLESTECH BUN/CREATININE TEST SYSTEM |
CHOLESTECH CORP. |
GARY HEWETT |
K964590 |
07/24/1997 |
COLORMATE III |
CHROMATICS COLOR SCIENCES INTL., INC. |
THOMMAS M TSAKERIS |
K963195 |
07/29/1997 |
WIRELESS EEG RECORDING SYSTEM MODEL W32 |
CME TELEMETRIX, INC. |
ANNE MARIE CESARIO |
K960974 |
07/14/1997 |
COBE CENTURY PERFUSION PUMP |
COBE CARDIOVASCULAR, INC. |
MARY L ARMSTRONG |
K971669 |
07/23/1997 |
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR |
COBE CARDIOVASCULAR, INC. |
MARY L ARMSTRONG |
K971597 |
07/29/1997 |
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) |
COLOPLAST CORP. |
RICHARD A HAMER |
K955890 |
07/28/1997 |
FIRST MEDIC PULSE OXIMETRY MODULE |
COLORADO MEDTECH, INC. |
BONNIE J NORMAN |
K970414 |
07/15/1997 |
CONFOCAL MICROSCOPE |
CON-S LTD. |
HERBERT E KAUFMAN, M.D. |
K972146 |
07/08/1997 |
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS |
CONSOLIDATED TECHNOLOGIES, INC. |
VIPIN D SHAH |
K963565 |
07/14/1997 |
MRI NEEDLES |
COOK, INC. |
APRIL LAVENDER |
K971646 |
07/14/1997 |
4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER |
CORDIS CORP. |
ELENA JUGO |
K971608 |
07/21/1997 |
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM |
CORDIS CORP. |
ELENA S JUGO |
K971579 |
07/18/1997 |
CORDIS OPTA 5 PTA BALLOON CATHETER |
CORDIS CORP. |
JODI LYNN GREENIZEN |
K971448 |
07/03/1997 |
CORDIS OPTA LP PTA BALLOON CATHETER |
CORDIS CORP. |
MIRJAM BARBOZA |
K971516 |
07/23/1997 |
CORDIS POWERFLEX PLUS PTA BALLOON CATHETER |
CORDIS CORP. |
MIRJAM BARBOZA |
K971572 |
07/14/1997 |
VISTA BRITE TIP CATHETERS |
CORDIS CORP. |
JACQUELINE ZIMOVAN |
K965247 |
07/23/1997 |
ENVOY GUIDING CATHETER |
CORDIS NEUROVASCULAR, INC. |
JODI FRASIER |
K971306 |
07/14/1997 |
FG INFUSION CATHETER |
CORDIS NEUROVASCULAR, INC. |
Lisa Wells |
K964230 |
07/24/1997 |
CORELIFE |
CORE HEALTHCARE LTD. |
KUMAR KULKARNI |
K970178 |
07/21/1997 |
CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM |
CORPAK, INC. |
ROBERT E BOOTH |
K965100 |
07/14/1997 |
N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT |
CRESTAT DIAGNOSTICS, INC. |
MARY REES |
K965024 |
07/14/1997 |
N-ASSAY TIA C1-INACTIVATOR TEST KIT |
CRESTAT DIAGNOSTICS, INC. |
MARY REES |
K964297 |
07/14/1997 |
N-ASSAY TIA C4 TEST KIT |
CRESTAT DIAGNOSTICS, INC. |
|
K965110 |
07/03/1997 |
N-ASSAY TIA MULTI CRP CALIBRATOR SET |
CRESTAT DIAGNOSTICS, INC. |
MARY REES |
K964300 |
07/14/1997 |
N-ASSAY TIA MULTI V-NL |
CRESTAT DIAGNOSTICS, INC. |
|
K964299 |
07/14/1997 |
N-ASSAY TIA MULTI V-NL |
CRESTAT DIAGNOSTICS, INC. |
|
K964301 |
07/14/1997 |
N-ASSAY TIA MULTI V-NL |
CRESTAT DIAGNOSTICS, INC. |
|
K964298 |
07/14/1997 |
N-ASSAY TIA MULTI V-NL |
CRESTAT DIAGNOSTICS, INC. |
|
K970995 |
07/07/1997 |
CMS CRYOLITE |
CRYOMEDICAL SCIENCES, INC. |
RICHARD J REINHART |
K970398 |
07/03/1997 |
SHARPS CONTAINER |
CUSTOM MEDICAL PLASTICS, INC. |
DANIEL R BROWN |
K970383 |
07/03/1997 |
SHARPS CONTAINER |
CUSTOM MEDICAL PLASTICS, INC. |
DANIEL R BROWN |
K970989 |
07/24/1997 |
CYBERREN |
CYBERNIUS MEDICAL LTD. |
ULRICH SIMONSMEIER |
K965128 |
07/14/1997 |
CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER |
CYNOSURE, INC. |
GEORGE CHO |
K971462 |
07/01/1997 |
SUNGLASSES |
D.G. PROVE CO. |
ANNE DINE |
K972287 |
07/07/1997 |
DADE TRU-LIQUID BILIRUBIN CONTROL |
DADE INTL., INC. |
RADHA GOOLABSINGH |
K965236 |
07/01/1997 |
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) |
DATASCOPE CORP. |
WILLIAM GOELLER |
K972153 |
07/31/1997 |
ALTERNATING PRESSURE AIR FLOTATION MATTRESS |
DECUBITI CONCEPTS, INC. |
JEAN ROZINT |
K971742 |
07/24/1997 |
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT |
DEPUY, INC. |
ARLENE C SAULL |
K972336 |
07/29/1997 |
DERMAMEND HYDROGEL GAUZE DRESSING |
DERMARX CORP. |
MARYANNE CARROLL |
K971792 |
07/25/1997 |
IMMULITE FREE T4 (2-STEP) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K971342 |
07/08/1997 |
DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) |
DISK WHISK, INC. |
RICK D ROBERTS |
K971641 |
07/21/1997 |
ANTIBACTERIAL GUTTA PERCHA |
DR. HOWARD MARTIN, P.A. |
KYLE H SIBINOVIC |
K961044 |
07/03/1997 |
NOVIGUARD QUICK DRY |
DR. NOVIS SMITH & CO., INC. |
NOVIS SMITH |
K971926 |
07/14/1997 |
QUIKSTRIP ONE STEP COCAINE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
K972528 |
07/28/1997 |
DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) |
DYNA CORP. |
HENRY C PERRY |
K971536 |
07/01/1997 |
RESTRAINTS (VESTS AND JACKETS) |
E.M. ADAMS CO., INC. |
RICHARD K DONAHUE |
K971459 |
07/18/1997 |
DERMALASE |
ENDO TECHNIC CORP. |
ANDREW KIMMEL |
K971598 |
07/18/1997 |
STERICHEK CHLORINE REAGENT STRIPS |
ENVIRONMENTAL TEST SYSTEMS, INC. |
DAVID A MORRIS |
K965172 |
07/16/1997 |
OXIMETER PRE-AMP CABLE |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
JEFFREY SECUNDA |
K972269 |
07/09/1997 |
DISPOSABLE PATIENT RETURN ELECTRODE |
ERBE USA, INC. |
MICHAEL A CLARK |
K963249 |
07/07/1997 |
EPILIGHT HAIR REMOVAL SYSTEM |
ESC MEDICAL SYSTEMS LTD. |
HILLEL BACHRACH |
K971302 |
07/07/1997 |
ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE |
ETHICON ENDO-SURGERY, INC. |
LONNIE PACE |
K971702 |
07/08/1997 |
FAR-EAST BARRIER GOWNS |
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
DAVID SONG |
K970988 |
07/10/1997 |
FAR-EAST BOUFFANT CAPS |
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
PING JIANG |
K971191 |
07/10/1997 |
FAR-EAST SHOE COVERS |
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
DAVID SONG |
K962159 |
07/18/1997 |
STERILE AMBULATORY RESERVOIR 60ML/100ML |
FAULDING MEDICAL DEVICE CO. |
BRUCE CRANEY |
K970819 |
07/14/1997 |
TARGOBEAM |
FERGUSON MEDICAL |
FRANK FERGUSON |
K971695 |
07/28/1997 |
SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER |
FISHER & PAYKEL ELECTRONICS LTD. |
CHRIS MANDER |
K971461 |
07/16/1997 |
SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) |
FISHER & PAYKEL ELECTRONICS LTD. |
CHRIS MANDER |
K970371 |
07/10/1997 |
FLOTEC OXYSAVRR (S) |
FLOTEC, INC. |
GILBERT DAVIDSON |
K970683 |
07/15/1997 |
ZENTIH FLOWABLE COMPOSITE (MULTIPLE) |
FOREMOST DENTAL MFG., INC. |
D.T. WOLF |
K971388 |
07/23/1997 |
FREERIDER, MODEL FR168-4 |
FREERIDER USA, INC. |
ROBERT S MCQUATE |
K971387 |
07/23/1997 |
FREERIDER, MODEL FR510-F |
FREERIDER USA, INC. |
ROBERT S MCQUATE |
K961465 |
07/03/1997 |
2008H ON LINE CLEARANCE MONITOR |
FRESENIUS USA, INC. |
TOM FOLDEN |
K972266 |
07/29/1997 |
GALLINI COAXIAL INTRODUCER |
GALLINI U.S., LLC. |
PAUL L HAWTHORNE |
K971667 |
07/23/1997 |
CARDIAC PHASED ARRAY COIL |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
K964886 |
07/29/1997 |
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEMS |
DAVID DUERSTELER |
K971668 |
07/24/1997 |
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
K965010 |
07/23/1997 |
TARGET 2 VERSION 1.1 |
GE MEDICAL SYSTEMS |
LARRY A KROGER, PH.D. |
K972338 |
07/24/1997 |
PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. |
GERIATRIC PRODUCTS, INC. |
E.J. Smith |
K972202 |
07/23/1997 |
DEEG-LITE |
GRASS-TELEFACTOR PRODUCT GROUP |
JAMES S BRYAN |
K970470 |
07/31/1997 |
EVT EXPANDABLE SHEATH |
GUIDANT CARDIAC AND VASCULAR SURGERY |
LUANNE TERMEER |
K971815 |
07/09/1997 |
ASC BALANCE MIDDLEWEIGHT GUIDE WIRE |
GUIDANT CORP. |
MONA MIRAPURI |
K971545 |
07/25/1997 |
PROTEGE LIQUID OXYGEN SYSTEM |
HEALTHDYNE TECHNOLOGIES, INC. |
JAY HAYES |
K971671 |
07/29/1997 |
HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) |
HEIDELBERG ENGINEERING |
GERHARD ZINSER |
K972348 |
07/24/1997 |
HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM |
HEWLETT-PACKARD CO. |
ROB BUTLER |
K964873 |
07/03/1997 |
SILKAIR LOW AIRLOSS THERAPY |
HILL-ROM, INC. |
EDWIN BILLS |
K971279 |
07/03/1997 |
VERSION 4 OPERATING SYSTEM SOFTWARE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES JOCHEN ROGERS |
K971566 |
07/14/1997 |
CREATINE KINASE-MB REAGENT SET |
HORIZON DIAGNOSTICS, INC. |
DAVID L CALLENDER |
K971741 |
07/16/1997 |
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE |
HOWMEDICA CORP. |
FRANK MAAS |
K971755 |
07/17/1997 |
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM |
HOWMEDICA CORP. |
JOHN DICHIARA |
K971550 |
07/08/1997 |
KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS |
HOWMEDICA CORP. |
MARGARET F CROWE |
K971854 |
07/30/1997 |
OSTEOLOCK ACETABULAR SHELL SYSTEM |
HOWMEDICA CORP. |
FRANK MAAS |
K961719 |
07/17/1997 |
EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES |
HOWMEDICA LEIBINGER, INC. |
ANDREW B ROGERS |
K970338 |
07/01/1997 |
TWEEZER-TYPE EPILATOR |
IGIA DIRECT, INC. |
JAMES R MARSHALL, PH.D. |
K971393 |
07/14/1997 |
MYCOPLASMA IGG ELISA TEST SYSTEM |
IMMUNO PROBE, INC. |
WILLIAM L BOTELER |
K971789 |
07/24/1997 |
IMPLEX CONTINUUM POROUS PATELLAR |
IMPLEX CORP. |
GLENN N BYRD |
K971620 |
07/22/1997 |
QUANTA LITE RUBEOLA (MEASLES) IGG |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K964036 |
07/18/1997 |
CARDIOMAGIC 2000 SOFTWARE |
INSTROMEDIX, INC. |
HERBERT H SEMLER |
K964408 |
07/23/1997 |
POSEIDON CARDIAC MONITORING SYSTEM (PCMS) |
INSTROMEDIX, INC. |
HERBERT J SEMLER, M.D. |
K971617 |
07/31/1997 |
ENDOSCOPIC VENTRICULAR CATHETER |
INTEGRA NEUROCARE LLC. |
LORI L HAYS |
K972006 |
07/10/1997 |
ACTA OEM MODULE |
INTERACTIVE CONSULTING, INC. |
JACKIE MASSE |
K971079 |
07/09/1997 |
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE |
INTERLOGICS, INC. |
DONALD R MCINTYRE |
K970300 |
07/03/1997 |
NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI |
INTERMEDICS ORTHOPEDICS |
LORI KLEINSCHRIDT HOLDER |
K972019 |
07/03/1997 |
PEFECT SHOT |
INTERNATIONAL IMAGING ELECTRONICS |
ROGER C CLAAR |
K971347 |
07/03/1997 |
MEDISURF |
INTERNATIONAL REGULATORY CONSULTANTS |
ELI M ORBACH |
K965001 |
07/31/1997 |
INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR |
INTUITIVE SURGICAL, INC. |
MICHAEL A DANIEL |
K971809 |
07/03/1997 |
ISOLATE |
IRVINE SCIENTIFIC SALES CO., INC. |
KEN LYDERSEN |
K971561 |
07/14/1997 |
PROVEST-PROTECTIVE RESTRAINT |
JEMM MEDICAL PRODUCTS |
ANGELITA KOWALEWSKY |
K965198 |
07/23/1997 |
ULTIMA TPS CEMENTED STEM |
JOHNSON & JOHNSON INTERNATIONAL |
JANET JOHNSON |
K971652 |
07/16/1997 |
P.F.C. SIGMA INSET PATELLA |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JOHN D FERROS |
K971189 |
07/17/1997 |
P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JOHN FERROS |
K971518 |
07/24/1997 |
KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MARLLENA ALLEN PIERCY |
K954320 |
07/18/1997 |
MODIFIED PEDIKAIR |
KINETIC CONCEPTS, INC. |
WILLIAM H QUIRK |
K971385 |
07/14/1997 |
SUNGLASSES |
KOSWAY INDUSTRIES CO., LTD. |
HENRY KO |
K961817 |
07/23/1997 |
B SMART MODEL 1 |
KOVEN TECHNOLOGY, INC. |
PAUL G KOVEN |
K971068 |
07/09/1997 |
34MM SCARF THREAD-HEAD(TM) SCREW |
LANDOS, INC. |
KATH LAFFAN |
K961732 |
07/08/1997 |
KAR |
LANDOS, INC. |
NORMAN F ESTRIN |
K971070 |
07/09/1997 |
SCARF THREAD-HEAD (TM) HEAD SCREW |
LANDOS, INC. |
KATH LAFFAN |
K971069 |
07/09/1997 |
TWIST-OFF (TM) SCREW |
LANDOS, INC. |
KATH LAFFAN |
K972272 |
07/29/1997 |
LASER PERIPHERALS HOLMIUM BARE FIBERS |
LASER PERIPHERALS LLC. |
NANCY L ARNOLD |
K972056 |
07/30/1997 |
STANDARD ENDOSCOPE |
LASER-OPTIK-SYSTEME GMBH & CO. KG |
MARC STRELOW |
K971843 |
07/23/1997 |
LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES |
LASERSCOPE |
LISA MCGRATH |
K972590 |
07/31/1997 |
NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES |
LBI U.S.A. |
KEITH LEHRER |
K971873 |
07/03/1997 |
LEVO ACTIVE-EASY LAE |
LEVO USA |
THOMAS RAEBER |
K971002 |
07/15/1997 |
SMILE WITH CONFIDENCE |
LLOYD V. ZIEMENDORF |
LLOYD V ZIEMENDORF |
K971647 |
07/15/1997 |
LL BI-FOCAL, DAILY WEAR CONTACT LENS |
LOMBART LENSES, LTD. |
LISA HAHN |
K971384 |
07/01/1997 |
(BRAND NAME) |
LONG IN TIME ENT. CO., LTD. |
PAUL LEE |
K971797 |
07/22/1997 |
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT |
LOUISVILLE LABORATORIES, INC. |
MARY MCNAMARA-CULLINANE |
K971801 |
07/22/1997 |
LAPAROTOMY BLADDER NECK SUSPENSION KIT |
LOUISVILLE LABORATORIES, INC. |
MARY MCNAMARA-CULLINANE |
K971802 |
07/30/1997 |
VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION |
LOUISVILLE LABORATORIES, INC. |
MARY MCNAMARA-CULLINANE |
K971791 |
07/30/1997 |
VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION |
LOUISVILLE LABORATORIES, INC. |
MARY MCNAMARA-CULLINANE |
K970657 |
07/01/1997 |
LMI THROMBECTOMY CATHETER |
LUCAS MEDICAL, INC. |
DANIEL LUCAS |
K972490 |
07/25/1997 |
D'ARC EYE CARE SUNGLASSES |
M & R DIST. |
MAX SHER |
K971473 |
07/07/1997 |
IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK |
M-PACT WORLDWIDE MANAGEMENT CORP. |
BARRY HALE |
K971832 |
07/31/1997 |
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK |
M-PACT WORLDWIDE MANAGEMENT CORP. |
BARRY HALE |
K970566 |
07/29/1997 |
ARGLAES FILM DRESSING |
MAERSK MEDICAL, LTD. |
DAVID MITCHELL |
K970478 |
07/16/1997 |
SCT 3000 HEATED HUMIDIFIER |
MARQUEST MEDICAL PRODUCTS, INC. |
THOMAS W DIELMANN |
K965167 |
07/25/1997 |
PERCUTANEOUS VENOUS INTRODUCER 10264 |
MEDAMICUS, INC. |
DAVID A LIEBL |
K971181 |
07/29/1997 |
THE MIDVIEW-MEDCON'S DICOM VIEWER |
MEDCON LTD. |
ELI M ORBACH |
K970011 |
07/09/1997 |
ESCORT II CLINICAL THERMOMETRY MODULE (CTM) |
MEDICAL DATA ELECTRONICS |
DAVID M TRUEBLOOD |
K970763 |
07/14/1997 |
MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR |
MEDICAL DATA ELECTRONICS |
DAVID M TRUEBLOOD |
K971916 |
07/29/1997 |
MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL |
MEDICAL Z, S.A. |
EMALEE G MURPHY |
K971996 |
07/31/1997 |
MEDIVISION ARTHROSCOP |
MEDIVISION SCOPE SERVICE CENTER, INC. |
WAYNE B STERNER |
K972126 |
07/29/1997 |
MYRINGOTOMY TUBE |
MEDNET LOCATOR, INC. |
CARROLL ALUNIUS |
K971943 |
07/23/1997 |
MYRINGOTOMY TUBE |
MEDNET LOCATOR, INC. |
JUDY S CHANDLER |
K972400 |
07/23/1997 |
MYRINGOTOMY TUBE - BOBBIN WITH TAB |
MEDNET LOCATOR, INC. |
JUDY S CHANDLER |
K971380 |
07/03/1997 |
MEDRAD FLEX INTERFACE DEVICE |
MEDRAD, INC. |
RODNEY J RYLANDS |
K964172 |
07/03/1997 |
MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL |
MEDTRONIC VASCULAR |
DAVID H MUELLER |
K971474 |
07/14/1997 |
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL |
MEDTRONIC VASCULAR |
LORNA J HARMUTH |
K963898 |
07/22/1997 |
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD |
MEDTRONIC VASCULAR |
SUSAN NODDIN |
K972273 |
07/08/1997 |
TBD |
MEGADYNE MEDICAL PRODUCTS, INC. |
JOHN W SMITH |
K970471 |
07/17/1997 |
MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) |
MENTOR CORP. |
CLARKE SCHERFF |
K971538 |
07/14/1997 |
MENTOR GEMINI HEMOSTATIC ERASER |
MENTOR OPHTHALMICS, INC. |
DAVID M DOWNEY |
K963190 |
07/01/1997 |
QA-40M DEFIBRILLATOR TESTER |
METRON U.S., INC. |
JIM QUINN |
K972259 |
07/10/1997 |
PRO CHECK DIGITAL PACIFIER THERMOMETER |
MICRO WEISS ELECTRONICS |
SUSAN D GOLDSTEIN-FALK |
K972431 |
07/23/1997 |
MERIDIAN DSP |
MICRO-EAR TECHNOLOGY, INC. |
DAVID PREVES |
K964646 |
07/15/1997 |
VIDEO EYE TRAKKER |
MICROMEDICAL TECHNOLOGIES, INC. |
MANISH SUMANT |
K964325 |
07/15/1997 |
VISUALEYES: VIDEO EYE MONITOR |
MICROMEDICAL TECHNOLOGIES, INC. |
MANISH SUMANT |
K972345 |
07/23/1997 |
DAHLBERG/MIRACLE-EAR |
MIRACLE-EAR, INC. |
MELANIE RASKA |
K972344 |
07/23/1997 |
MIRACLE-EAR DIGITAL BTE |
MIRACLE-EAR, INC. |
MELANIE RASKA |
K972346 |
07/23/1997 |
MIRACLE-EAR ITE DIGITAL |
MIRACLE-EAR, INC. |
MELANIE RASKA |
K972416 |
07/21/1997 |
MOMO DESIGN OR MOMO |
MOMO U.S.A., INC. |
PHILIP MOORE |
K971835 |
07/03/1997 |
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA |
MONOBIND |
FREDERICK R JEROME |
K971834 |
07/03/1997 |
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA |
MONOBIND |
FREDERICK R JEROME |
K971437 |
07/22/1997 |
BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 |
MURRAY ELECTRONICS |
KENT C HOFFMAN |
K963987 |
07/23/1997 |
CAMOUFLAGE CUFF SAVERS |
N.A. BRAGGS MEDICAL, INC. |
JACQUELINE BRACKETT |
K971687 |
07/29/1997 |
HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME |
NATIONAL MEDICAL CARE, INC. |
DEBRA L BING |
K971642 |
07/24/1997 |
DENTALIS KEZ ENDODONITC SEALER |
NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
KYLE H SIBINOVIC |
K965179 |
07/03/1997 |
INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO |
NEO IMAGERY TECHNOLOGIES, INC. |
TINA YOUNG |
K965079 |
07/10/1997 |
SOMNITOR 32K SLEEP ACTIVITY MONITOR |
NEURIM PHARMACEUTICALS, LTD. |
T. WHIT ATHEY |
K963208 |
07/14/1997 |
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) |
NEUROTRON MEDICAL |
JACK GULDALIAN, JR. |
K972001 |
07/08/1997 |
NICAS(TM) ELECTRODE |
NI MEDICAL |
BARRY SALL |
K971194 |
07/09/1997 |
NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES |
NIHON KOHDEN AMERICA, INC. |
GARY REASONER |
K971355 |
07/15/1997 |
NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES |
NIHON KOHDEN AMERICA, INC. |
GARY REASONER |
K971706 |
07/21/1997 |
TIADAPT ABUTMENT SYSTEM |
NOBEL BIOCARE UAS INC |
BETSY A BROWN |
K971546 |
07/10/1997 |
SOMA 900 TRANSPORT BED |
NOVA TECHNOLOGIES, INC. |
SAMUEL N PAUL |
K972253 |
07/29/1997 |
P3 UNIVERSAL PHACO HANDPIECE |
ODYSSEY TECHNOLOGIES, INC. |
GLENN A DUNKI-JACOBS |
K972252 |
07/29/1997 |
VISTA UNIVERSAL HANDPIECE |
ODYSSEY TECHNOLOGIES, INC. |
GLENN A DUNKI-JACOBS |
K971328 |
07/01/1997 |
OLYMPUS CD-6C-1 COAGULATION ELECTRODE |
OLYMPUS AMERICA, INC. |
SUBHASH R PATEL |
K971660 |
07/25/1997 |
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT |
OLYMPUS AMERICA, INC. |
SUBHASH R PATEL |
K971416 |
07/16/1997 |
OLYMPUS OES OTV-S5C VIDEO SYSTEM |
OLYMPUS AMERICA, INC. |
SUBHASH R PATEL |
K970770 |
07/14/1997 |
LATEX EXAMINATION GLOVES |
OON CORP. RESOURCES |
CLEMENT K K.OON |
K972373 |
07/29/1997 |
OVATION HDP |
ORSONIQUE, INC. |
EUGENE ALEXANDRESCU |
K971435 |
07/09/1997 |
HEADLOC CERAMIC FEMORAL HEADS |
ORTHO DEVELOPMENT CORP. |
CAROL J FREASIER |
K971426 |
07/09/1997 |
HEADLOC CERAMIC HEAD |
ORTHO DEVELOPMENT CORP. |
CAROL J FREASIER |
K971581 |
07/18/1997 |
HEMISPHERE CEMENTED CUP |
ORTHO DEVELOPMENT CORP. |
CAROL FREASIER |
K951459 |
07/14/1997 |
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
JOANNE HARRIS |
K963789 |
07/14/1997 |
DTX-100 BONE DENSITOMETER |
OSTEOMETER MEDITECH A/S |
BERT HUDSON |
K971800 |
07/30/1997 |
OSTEO CANNULATED SCREW SYSTEM |
OSTEONICS CORP. |
KATE SUTT0N |
K971321 |
07/09/1997 |
OSTEO COMPRESSION CONDYLE SCREW SYSTEM |
OSTEONICS CORP. |
DONNA S WILSON |
K971654 |
07/09/1997 |
OSTEO COMPRESSION HIP SCREW SYSTEM |
OSTEONICS CORP. |
DONNA S WILSON |
K971409 |
07/09/1997 |
OSTEONICS ALUMINA C-TAPER HEAD |
OSTEONICS CORP. |
KATE SUTTON |
K971497 |
07/16/1997 |
OSTEONICS ANTEVERTED NECK HIP STEM |
OSTEONICS CORP. |
DONNA S WILSON |
K963848 |
07/07/1997 |
MANUAL RESUSCITATOR |
OWENS-BRIGAM MEDICAL CO. |
BILL BROOKS |
K972330 |
07/14/1997 |
INNOFLUOR PHENOBARBITAL ASSAY SYSTEM |
OXIS INTL., INC. |
LYNDA M TAYLOR |
K971635 |
07/03/1997 |
AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K971631 |
07/03/1997 |
CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K971633 |
07/03/1997 |
PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K971795 |
07/14/1997 |
AUTOMATED CHAMBER MAINTENANCE MODULE |
PARADIGM MEDICAL INDUSTRIES, INC. |
RICHARD DIRKSON |
K971589 |
07/24/1997 |
REACH ANTIBACTERIAL TOOTHBRUSH |
PERSONAL PRODUCTS CO. |
LORNA-JANE BREMER |
K972068 |
07/03/1997 |
UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 |
PHARMACIA, INC. |
KAREN E MATIS |
K971489 |
07/03/1997 |
RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
FRANK GIANELLI |
K972097 |
07/30/1997 |
PHONAK MICROZOOM P 2 |
PHONAK, INC. |
LAURA M VOLL |
K972671 |
07/20/1997 |
BUN (LIQUID) REAGENT SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
K971754 |
07/22/1997 |
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
K964425 |
07/28/1997 |
A-V IMPULSE SYSTEM MODEL 6060 |
POWELL,GOLDSTEIN,FRAZER & MURPHY |
WILLIAM H.E. VON OEHSEN |
K971226 |
07/18/1997 |
CRYO CHECK FACTOR IX DEFICIENT PLASMA |
PRECISION BIOLOGICALS, INC. |
STEPHEN L DUFF |
K971223 |
07/22/1997 |
CRYO CHECK FACTOR V DEFICIENT PLASMA |
PRECISION BIOLOGICALS, INC. |
STEPHEN L DUFF |
K971224 |
07/17/1997 |
CRYO CHECK FACTOR VII DEFICIENT PLASMA |
PRECISION BIOLOGICALS, INC. |
STEPHEN L DUFF |
K971225 |
07/17/1997 |
CRYO CHECK FACTOR VIII DEFICIENT PLASMA |
PRECISION BIOLOGICALS, INC. |
STEPHEN L DUFF |
K971227 |
07/18/1997 |
CRYO CHECK FACTOR X DEFICIENT PLASMA |
PRECISION BIOLOGICALS, INC. |
STEPHEN L DUFF |
K971349 |
07/07/1997 |
BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
K971722 |
07/10/1997 |
TRANS VAGINAL NEEDLE GUIDE |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
K971278 |
07/03/1997 |
PURE COMPANY FLUID DELIVERY SYSTEM |
PURE CO. |
GARY S NUNNELLY |
K972170 |
07/24/1997 |
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION |
R & D SYSTEMS, INC. |
KENNETH EDDS |
K972172 |
07/24/1997 |
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION |
R & D SYSTEMS, INC. |
SUE GALLO |
K971511 |
07/24/1997 |
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE |
RADIONICS, INC. |
LINDA JALBERT |
K972000 |
07/08/1997 |
X-RAY ASSIST BAR |
RALPH LINDEL, D.C. |
SUSAN D GOLDSTEIN-FALK |
K971825 |
07/24/1997 |
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST |
RANDOX LABORATORIES, LTD. |
PONE ARMSTRONG |
K971968 |
07/23/1997 |
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) |
REMINGTON MEDICAL, INC. |
DON ROSVOLD |
K970739 |
07/08/1997 |
RMI HEMOCONCENTRATOR PREFERENCE PACK |
RESEARCH MEDICAL, INC. |
R.D. HIBBERT |
K971605 |
07/03/1997 |
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION |
RESOUND CORP. |
KRISTA M BUCKLES |
K971568 |
07/18/1997 |
REST MATTRESS |
REST MATTRESS |
YOAV GERSHONI |
K964920 |
07/09/1997 |
RPI DUAL PORT IRRIGATION ADAPTER |
RIDGE PRODUCTS, INC. |
RICHARD G VOELKER |
K971337 |
07/09/1997 |
EPITECH ISLAND DRESSINGS |
RYNEL LTD, INC. |
TIM THOMSON |
K972302 |
07/25/1997 |
POCKET COUNT OR SAFETCOUNT |
SAGE PRODUCTS, INC. |
KAREN PINTO |
K972026 |
07/09/1997 |
SP4044 & SP4055 LUX MODULES |
SATELEC |
JACKIE MASSE |
K971404 |
07/09/1997 |
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER |
SCHWARTZ ELECTRO-OPTICS, INC. |
TIMOTHY J SHEA |
K971743 |
07/18/1997 |
SHARPLAN CO2 SURGICAL LASER SYSTEM |
SHARPLAN LASERS, INC. |
GEORGE J HATTUB |
K971648 |
07/23/1997 |
SHARPLAN ERBIUM: YAG LASER (4020) |
SHARPLAN LASERS, INC. |
GEORGE J HATTUB |
K970920 |
07/29/1997 |
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Jacqueline Emery |
K972794 |
07/31/1997 |
DIGOXIN DG-II FPIA REAGENT SET |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
K972041 |
07/22/1997 |
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
K972144 |
07/25/1997 |
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
K972132 |
07/30/1997 |
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
K961392 |
07/18/1997 |
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II |
SIL-MED CORP. |
KAREN K SYLVIA |
K971666 |
07/03/1997 |
SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES |
SJ MEDICAL PRODUCTS (M) SDN BHD |
FOO KHON PU |
K972123 |
07/25/1997 |
PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 |
SMITH |
E.J. Smith |
K971414 |
07/16/1997 |
ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS |
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
JOANN KUHNE |
K970051 |
07/10/1997 |
MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE |
SMITH AND NEPHEW DONJOY, INC. |
DAN W MILLER |
K963780 |
07/30/1997 |
DUAL ROD ANTERIOR FIXATOR SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
K971450 |
07/17/1997 |
SOMNOPLASTY SYSTEM |
SOMNUS MEDICAL TECHNOLOGIES, INC. |
EVE CONNER |
K971533 |
07/25/1997 |
VIBRA-SURGE SYSTEM MODEL VS2120 |
SONICS & MATERIALS, INC. |
ROBERT SOLOFF |
K970318 |
07/07/1997 |
OCULAR CONFORMER |
SOUTHWEST ARTIFICIAL EYES, INC. |
DANIEL M WENSKE |
K970327 |
07/07/1997 |
SCLERAL SHELL |
SOUTHWEST ARTIFICIAL EYES, INC. |
DANIEL M WENSKE |
K972408 |
07/25/1997 |
CARDIAC STATUS CONTROLS |
SPECTRAL DIAGNOSTICS, INC. |
FRANCEE S BOCHES |
K972687 |
07/28/1997 |
CARDIAC STATUS CONTROLS/TROPONIN I |
SPECTRAL DIAGNOSTICS, INC. |
FRANCEE S BOCHES |
K972155 |
07/17/1997 |
CREATINE KINASE (CK) |
STANBIO LABORATORY |
KIRK JOHNSON |
K963777 |
07/28/1997 |
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 |
STEPHENSON INDUSTRIES, INC. |
R A LASHLY |
K970073 |
07/03/1997 |
BIO-ESTHETIC INDIRECT ABUTMENT |
STERI-OSS, INC. |
JEFF HAUSHEER, PH.D. |
K972069 |
07/29/1997 |
STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK |
STRYKER INSTRUMENTS |
TAMMMY LOUNDS |
K971138 |
07/21/1997 |
DINABASE (TM) |
SULTAN CHEMISTS, INC. |
LES HEIMANN |
K971770 |
07/31/1997 |
APOLLO KNEE FEMORAL SPACERS |
SULZER ORTHOPEDICS, INC. |
JACQUELYN HUGHES |
K972362 |
07/14/1997 |
FOVS, BRILLARTE, ETC... |
SUNGLASS CITY, INC. |
AULIO GIRON |
K971675 |
07/14/1997 |
SNT STEREOTACTIC LOCALIZATION SYSTEM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
K970481 |
07/01/1997 |
V2 |
SURVIVALINK CORP. |
SEW-WAY TAY |
K971783 |
07/18/1997 |
SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
K971009 |
07/29/1997 |
SCAR CARE |
TARGET HEALTH, INC. |
JULES T MITCHEL |
K971395 |
07/14/1997 |
GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE |
TARGET THERAPEUTICS |
ROXANE K BAXTER |
K971849 |
07/24/1997 |
CYTOLOGY BRUSH |
TEAM TECHNOLOGIES, INC. |
BOB WALTON |
K971182 |
07/22/1997 |
TOX A/B TEST |
TECHLAB, INC. |
DAVID M LYERLY |
K971472 |
07/01/1997 |
SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA |
TECHNICAL PRODUCTS, INC. |
NORBERT D THOMPSON |
K970548 |
07/03/1997 |
ONE STEP MARIJUANA CARD TEST |
TECO DIAGNOSTICS |
ANDREW REAMS |
K970579 |
07/03/1997 |
ONE STEP MORPHINE CARD TEST |
TECO DIAGNOSTICS |
ANDREW REAMS |
K971949 |
07/28/1997 |
POWDER-FREE PATIENT EXAMINATION GLOVES |
TEKMEDIC (M) SDN BHD |
KOPK-KEE HON |
K961734 |
07/07/1997 |
CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
K972094 |
07/23/1997 |
TARGET CARDIAC TROPONIN I TEST |
TEXAS IMMUNOLOGY, INC. |
CHARLES W GILL |
K970547 |
07/18/1997 |
ISOLYSER SDS SHARPS CONTAINER |
THANTEX SPECIALTIES, INC. |
TOM BONNER |
K972237 |
07/31/1997 |
HAND HELD MEDISPACER |
THAYER MEDICAL CORP. |
JOE LIX |
K972038 |
07/03/1997 |
INTRUDER |
THE BUZZZ CORP. |
KEN CASEY |
K972037 |
07/03/1997 |
PROWLER |
THE BUZZZ CORP. |
KEN CASEY |
K972036 |
07/03/1997 |
STEALTH |
THE BUZZZ CORP. |
KEN CASEY |
K970236 |
07/09/1997 |
THERAPLAN PLUS VERSION 1.2 |
THERATRONICS, INC. |
E.S. MARTELL |
K964092 |
07/31/1997 |
TMS COMFORT SERIES NASAL CPAP MASK |
TIARA MEDICAL SYSTEMS, INC. |
NORBERT E CICHON |
K971945 |
07/14/1997 |
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE |
TILLOTSON HEALTHCARE CORP. |
EDWARD MARKOVIC |
K965068 |
07/15/1997 |
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
JAVAD SEYEDZADEH |
K970573 |
07/21/1997 |
FLEXART V3.5 SOFTWARE |
TOSHIBA AMERICA MRI, INC. |
JAVAD SEYEDZADEH |
K972297 |
07/17/1997 |
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
TRACE AMERICA, INC. |
David Johnston |
K971615 |
07/24/1997 |
PATTISON ESOPHAGEAL DILATOR |
TRI-MED SPECIALTIES, INC. |
MIKE KNOTH |
K972552 |
07/30/1997 |
AUDIFON H20 PC/AUDIFON H32 PP |
TRUTONE |
ZIAD SHWIYAT |
K972550 |
07/31/1997 |
AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC |
TRUTONE |
ZIAD SHWIYAT |
K972542 |
07/23/1997 |
JAZZ PP AGC-O, JAZZ PP |
TRUTONE |
ZIAD SHWIYAT |
K972543 |
07/23/1997 |
TWIST PPAGC-1, TWIST PP |
TRUTONE |
ZIAD SHWIYAT |
K970191 |
07/03/1997 |
UNIJECT EXAMINATION GLOVES |
UNIJECT GLOVES LTD. |
SYED BABER |
K970160 |
07/15/1997 |
UNIJECT SURGICAL GLOVES |
UNIJECT GLOVES LTD. |
SYED BABER |
K970793 |
07/30/1997 |
IMPLANTABLE CLIP |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR CLAVELLI |
K971861 |
07/01/1997 |
ULTRASONIC HAND INSTRUMENTS |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR CLAVELLI |
K972288 |
07/14/1997 |
FACTOR DEFICIENT PLASMAS - FACTOR IX (9) |
UNIVERSAL REAGENTS, INC. |
JORGE MILLER |
K972286 |
07/14/1997 |
FACTOR DEFICIENT PLASMAS - FACTOR XI (11) |
UNIVERSAL REAGENTS, INC. |
JORGE MILLER |
K965245 |
07/03/1997 |
TBD |
UTAH MEDICAL PRODUCTS, INC. |
JOHN W SMITH |
K962950 |
07/22/1997 |
CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
CHARLES H WILL |
K964821 |
07/16/1997 |
COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 |
VENTREX, INC. |
ROBERT B GUTHRIE |
K972333 |
07/23/1997 |
AMMONIA/IRON STANDARD KIT |
VERICHEM LABORATORIES, INC. |
ANTHONY J DIMONTE |
K964952 |
07/21/1997 |
VERIDOSE V (FIVE), MODEL NUMBER 37-705 |
VICTOREEN, INC. |
LINDA S MORIN |
K964874 |
07/01/1997 |
HSV-1 ANTIGEN CONTROL SLIDES |
VIRAL ANTIGENS, INC. |
TERRY S RATCLIFFE |
K971101 |
07/01/1997 |
HSV-2 ANTIGEN CONTROL SLIDES |
VIRAL ANTIGENS, INC. |
TERRY S RATCLIFFE |
K971776 |
07/14/1997 |
ECHOVACS |
VMI TECHNOLOGIES |
DOUG SEABORN |
K972074 |
07/25/1997 |
SUCTION INSTRUMENTATION |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
K971571 |
07/29/1997 |
RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT |
WATERS INSTRUMENTS, INC. |
DAVE SCHOLLMAN |
K971734 |
07/29/1997 |
VG 200 VIDEO GASTROSCOPE |
WELCH ALLYN, INC. |
LAWRENCE E MAROCCO |
K971764 |
07/29/1997 |
WELCON HUE-VU URINARY DRAINAGE BAG |
WELCON, INC. |
GEORGE HIRD |
K971718 |
07/23/1997 |
MICRO-SEAL ACETABULAR SYSTEM |
WHITESIDE BIOMECHANICS, INC. |
MICHAEL C WALL |
K971721 |
07/30/1997 |
WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD |
WHITESIDE BIOMECHANICS, INC. |
MICHAEL C WALL |
K971429 |
07/09/1997 |
INTERSEAL ACETABULAR SCREW HOLE PLUG |
WRIGHT MEDICAL TECHNOLOGY, INC. |
CRISTIE MANUEL |
K970319 |
07/07/1997 |
OCULAR CONFORMER |
XAVIER A. GUERRA, OCULARIST, INC. |
XAVIER A GUERRA |
K970320 |
07/07/1997 |
SCLERAL SHELL |
XAVIER A. GUERRA, OCULARIST, INC. |
XAVIER A GUERRA |
K971784 |
07/23/1997 |
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
K972027 |
07/16/1997 |
ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) |
ZHERMACK S.P.A. |
EVAN DICK |
K971752 |
07/30/1997 |
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER) |
ZIMMER, INC. |
KAREN CAIN |